U.S. patent application number 16/636170 was filed with the patent office on 2020-11-26 for atrial cage for placement, securing and anchoring of atrioventricular valves.
The applicant listed for this patent is The Regents of the University of California. Invention is credited to Gregory S. Kelley, Arash KHERADVAR.
Application Number | 20200368023 16/636170 |
Document ID | / |
Family ID | 1000005036036 |
Filed Date | 2020-11-26 |
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United States Patent
Application |
20200368023 |
Kind Code |
A1 |
KHERADVAR; Arash ; et
al. |
November 26, 2020 |
ATRIAL CAGE FOR PLACEMENT, SECURING AND ANCHORING OF
ATRIOVENTRICULAR VALVES
Abstract
Described is a collapsible atrial cage for percutaneous delivery
and implantation of an atrioventricular valve within an atrium of
the heart. The atrial cage includes an atrial portion and a
ventricular portion. The ventricular portion is attached with and
separated from the atrial portion by a valve juncture portion.
Notably, the cage includes at least one interlock shaped to lock
with and secure an atrioventricular valve proximate the valve
juncture portion. Thus, when deployed and expanded, the
atrioventricular valve is secured at the atrioventricular
juncture.
Inventors: |
KHERADVAR; Arash; (Irvine,
CA) ; Kelley; Gregory S.; (Santee, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
The Regents of the University of California |
Oakland |
CA |
US |
|
|
Family ID: |
1000005036036 |
Appl. No.: |
16/636170 |
Filed: |
August 2, 2018 |
PCT Filed: |
August 2, 2018 |
PCT NO: |
PCT/US2018/045030 |
371 Date: |
February 3, 2020 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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62540916 |
Aug 3, 2017 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61F 2220/0025 20130101;
A61F 2210/0014 20130101; A61F 2/2415 20130101; A61F 2/2487
20130101; A61F 2/2418 20130101 |
International
Class: |
A61F 2/24 20060101
A61F002/24 |
Goverment Interests
GOVERNMENT RIGHTS
[0002] This invention was made with Government support under Grant
No. HL119893, awarded by the National Institutes of Health. The
Government has certain rights in this invention.
Claims
1. An atrial cage for placement, securing and anchoring of
atrioventricular valves, the atrial cage comprising: an atrial
portion; and a ventricular portion attached with and separated from
the atrial portion by a valve juncture portion.
2. The atrial cage as set forth in claim 1, further comprising at
least one interlock shaped to lock with and secure an
atrioventricular valve proximate the valve juncture portion.
3. The atrial cage as set forth in claim 1, wherein each interlock
includes a tip clasp and a base clasp, whereby the tip clasp is
shaped to lock with a valve catch tip and the base clasp is shaped
to at least partially wrap around a valve catch base.
4. The atrial cage as set forth in claim 1, wherein the atrial cage
is collapsible and expandable, such that when expanded, each of the
atrial portion, ventricular portion and valve juncture portion have
a diameter such that the diameter of the atrial portion and
ventricular portion is greater than the diameter of the valve
juncture portion.
5. The atrial cage as set forth in claim 1, wherein the atrial cage
is a wire cage.
6. The atrial cage as set forth in claim 1, wherein the atrial cage
is laser-cut from a tube
7. The atrial cage as set forth in claim 1, wherein the atrial cage
is wire cage formed of Nitinol wire.
8. The atrial cage as set forth in claim 1, wherein the atrial cage
is self-expandable.
9. The atrial cage as set forth in claim 1, wherein the atrial cage
is balloon-expandable.
10. The atrial cage as set forth in claim 1, further comprising an
atrioventricular valve secured proximate the constricted portion of
the atrial cage, whereby the cage is securely attached to the
atrioventricular valve before delivery to an atrium using a
transcatheter delivery system.
11. The atrial cage as set forth in claim 1, wherein the atrial
cage is formed in whole or part of a dissolving material, whereby
the atrial cage may gradually resorb or dissolve away after some
time period and after an atrioventricular valve becomes secured to
an atrioventricular juncture.
12. The atrial cage as set forth in claim 1, wherein the atrial
cage is sized and shaped according to medical imaging to fit or
conform with atrial anatomy of a subject.
13. The atrial cage as set forth in claim 1, wherein the atrial
cage is sized and shaped such that once deployed and expanded, at
least a part of the cage is in contact with the atrial wall.
14. The atrial cage as set forth in claim 1, wherein the atrial
cage is sized and shaped based on three-dimensional scanning of a
subject to fit the subject's anatomy.
15. The atrial cage as set forth in claim 1, wherein the atrial
cage is formed through three-dimensional printing.
16. The atrial cage as set forth in claim 1, wherein the atrial
cage is collapsible over a catheter for percutaneous delivery and
deployable alone for subsequent delivery and attachment of a
valve.
17. The atrial cage as set forth in claim 1, wherein the atrial
cage includes a valve collapsed therein and is collapsible over a
catheter for percutaneous delivery and deployment simultaneously
with the valve.
18. A method for percutaneously delivering and implantation of an
atrial cage, comprising acts of: delivering an atrial cage with a
delivery system to a desired location inside a subject's heart
chamber, such that during delivery, the atrial cage is collapsed
within a sheath of the delivery system; retracting the sheath to
deploy the atrial cage at the desired location, such that upon
deployment the atrial cage expands at the desired location;
delivering a valve with a delivery system to a desired location
within the deployed atrial cage; and releasing and implanting the
heart valve at the desired location within the deployed atrial
cage.
19. A method for percutaneously delivering and implantation of an
atrial cage having a valve therein, comprising acts of: delivering
an atrial cage having valve therein with a delivery system to a
desired location inside a subject's heart chamber, such that during
delivery, both the atrial cage and valve are collapsed within a
sheath of the delivery system; retracting the sheath to deploy the
atrial cage at the desired location, such that upon deployment,
both the atrial cage and valve expand at the desired location; and
releasing and implanting the atrial cage with attached heart valve
at the desired location.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This is a National Stage filing of PCT/US18/45030, filed on
Aug. 2, 2018, which claims the benefit of priority of U.S.
Provisional Application No. 62/540,916, filed Aug. 3, 2017, the
entirety of which are incorporated herein by reference.
BACKGROUND OF THE INVENTION
(1) Field of Invention
[0003] The present invention relates to heart valves and, more
particularly, to a collapsible cage for percutaneous delivery and
implantation of an atrioventricular valve within an atrium of the
heart.
(2) Description of Related Art
[0004] Valvular heart disease is the third-most common cause of
heart problems in the United States. While artificial valves have
been developed to address such heart problems, such valves are
often difficult to implant in a patient. Due to its minimally
invasive nature, the percutaneous approach to aortic valve
implantation has been a success, sparing patients aggressive
surgery and reducing associated comorbidities. The lure of
percutaneous technologies provides cost effective solutions to
heart valve disease, thereby allowing more timely interventions
with acceptable efficacy and minimal complications, especially for
patients who cannot undergo surgery. Nevertheless, a problem with
existing techniques is that they are difficult to securely anchor
the transcatheter atrioventricular valve prosthesis at the
atrioventricular junction (annulus).
[0005] Thus, a continuing need exists for a system for percutaneous
delivery and implantation of an atrioventricular valve within an
atrium of the heart that allows the transcatheter atrioventricular
valve (AV) to be securely placed and anchored at the AV
junction.
SUMMARY OF INVENTION
[0006] The present invention relates to heart valves and, more
particularly, to a collapsible atrial cage for percutaneous
delivery and implantation of an atrioventricular valve within an
atrium of the heart. The atrial cage includes an atrial portion and
a ventricular portion attached with and separated from the atrial
portion by a valve juncture portion.
[0007] In other aspects, the atrial cage includes at least one
interlock shaped to lock with and secure an atrioventricular valve
proximate the valve juncture portion. Additionally, each interlock
includes a tip clasp and a base clasp, whereby the tip clasp is
shaped to lock with a valve catch tip and the base clasp is shaped
to at least partially wrap around a valve catch base.
[0008] In another aspect, the atrial cage is collapsible and
expandable, such that when expanded, each of the atrial portion,
ventricular portion and valve juncture portion have a diameter such
that the diameter of the atrial portion and ventricular portion is
greater than the diameter of the valve juncture portion.
[0009] In yet another aspect, the atrial cage is a wire cage.
[0010] In another aspect, the atrial cage is wire cage formed of
Nitinol wire.
[0011] Further and in yet another aspect, the atrial cage is
self-expandable.
[0012] Additionally and in another aspect, the atrial cage is
balloon-expandable.
[0013] In another aspect, an atrioventricular valve is secured
proximate the constricted portion of the atrial cage, whereby the
cage is securely attached to the atrioventricular valve before
delivery to an atrium using a transcatheter delivery system.
[0014] In another aspect, the atrial cage is formed in whole or
part of a dissolving material, whereby the atrial cage may
gradually resorb or dissolve away after some time period and after
an atrioventricular valve becomes secured to an atrioventricular
juncture.
[0015] Additionally, the atrial cage is sized and shaped according
to medical imaging to fit or conform with atrial anatomy of a
subject.
[0016] Further the atrial cage is sized and shaped such that once
deployed and expanded, at least a part of the cage is in contact
with the atrial wall.
[0017] In another aspect, the atrial cage is sized and shaped based
on three-dimensional scanning of a subject to fit the subject's
anatomy.
[0018] In yet another aspect, the atrial cage is laser-cut from a
tube
[0019] Additionally, the atrial cage is formed through
three-dimensional printing.
[0020] In yet another aspect, the atrial cage is collapsible over a
catheter for percutaneous delivery and deployable alone for
subsequent delivery and attachment of a valve.
[0021] In another aspect, the atrial cage includes a valve
collapsed therein and is collapsible over a catheter for
percutaneous delivery and deployment simultaneously with the
valve.
[0022] In other aspects and as can be appreciated by one skilled in
the art, the present invention also comprises a method for using
the atrial cage as described herein. For example, this disclosure
provides a method for percutaneously delivering and implantation of
an atrial cage, comprising acts of: delivering an atrial cage with
a delivery system to a desired location inside a subject's heart
chamber, such that during delivery, the atrial cage is collapsed
within a sheath of the delivery system; retracting the sheath to
deploy the atrial cage at the desired location, such that upon
deployment the atrial cage expands at the desired location;
delivering a valve with a delivery system to a desired location
within the deployed atrial cage; and releasing and implanting the
heart valve at the desired location within the deployed atrial
cage.
[0023] In another aspect, the method for percutaneously delivering
and implantation of an atrial cage having a valve therein comprises
acts of: delivering an atrial cage having valve therein with a
delivery system to a desired location inside a subject's heart
chamber, such that during delivery, both the atrial cage and valve
are collapsed within a sheath of the delivery system; retracting
the sheath to deploy the atrial cage at the desired location, such
that upon deployment, both the atrial cage and valve expand at the
desired location; and releasing and implanting the atrial cage with
attached heart valve at the desired location.
[0024] Finally, as can be appreciated by one in the art, the
present invention also comprises a method for forming atrial cage
and components as described herein.
BRIEF DESCRIPTION OF THE DRAWINGS
[0025] The objects, features and advantages of the present
invention will be apparent from the following detailed descriptions
of the various aspects of the invention in conjunction with
reference to the following drawings, where:
[0026] FIG. 1 is a front-view illustration of an atrial cage
according to various embodiments of the present invention;
[0027] FIG. 2 is a rear-view illustration of the atrial cage
according to various embodiments of the present invention;
[0028] FIG. 3 is a left-view illustration of the atrial cage
according to various embodiments of the present invention;
[0029] FIG. 4 is a right-view illustration of the atrial cage
according to various embodiments of the present invention;
[0030] FIG. 5 is a top-view illustration of the atrial cage
according to various embodiments of the present invention;
[0031] FIG. 6 is a bottom-view illustration of the atrial cage
according to various embodiments of the present invention;
[0032] FIG. 7A is a front-view illustration of an example valve as
can be delivered using the atrial cage according to various
embodiments of the present invention;
[0033] FIG. 7B is a rear-view illustration of the example valve as
illustrated in FIG. 7A;
[0034] FIG. 7C is an isometric-view illustration of the example
valve as illustrated in FIG. 7A;
[0035] FIG. 8A is a front, close-up view illustration of an
interlock as formed on the atrial cage according to various
embodiments of the present invention;
[0036] FIG. 8B is a bottom, close-up view illustration of the
interlock according to various embodiments of the present
invention;
[0037] FIG. 8C is an isometric, close-up view illustration of the
interlock according to various embodiments of the present
invention;
[0038] FIG. 9A is a front, close-up view illustration of the
interlock, depicting the interlock as connected with a valve
according to various embodiments of the present invention;
[0039] FIG. 9B is a bottom, close-up view illustration of the
interlock connected with the valve according to various embodiments
of the present invention;
[0040] FIG. 9C is an isometric, close-up view illustration of the
interlock connected with the valve according to various embodiments
of the present invention;
[0041] FIG. 10 is a front-view illustration of the atrial cage,
depicting the atrial cage and corresponding interlock as connected
with a valve according to various embodiments of the present
invention;
[0042] FIG. 11 is a rear-view illustration of the atrial cage,
depicting the atrial cage and corresponding interlock as connected
with a valve according to various embodiments of the present
invention;
[0043] FIG. 12 is a left-view illustration of the atrial cage,
depicting the atrial cage and corresponding interlock as connected
with a valve according to various embodiments of the present
invention;
[0044] FIG. 13 is a right-view illustration of the atrial cage,
depicting the atrial cage and corresponding interlock as connected
with a valve according to various embodiments of the present
invention;
[0045] FIG. 14 is a top-view illustration of the atrial cage,
depicting the atrial cage and corresponding interlock as connected
with a valve according to various embodiments of the present
invention;
[0046] FIG. 15 is a bottom-view illustration of the atrial cage,
depicting the atrial cage and corresponding interlock as connected
with a valve according to various embodiments of the present
invention;
[0047] FIG. 16A is an interior-view illustration of a heart
chamber, depicting a native mitral valve annulus;
[0048] FIG. 16B is an interior-view illustration of the heart
chamber, depicting the atrial cage and a bioprosthetic mitral valve
as attached with the native mitral valve according to various
embodiments of the present invention;
[0049] FIG. 17 is an illustration depicting an example of a locking
configuration of an interlock and catch according to various
embodiments of the present invention;
[0050] FIG. 18A is a side-view illustration depicting the atrial
cage in a collapsed configuration without a valve prosthesis
therein;
[0051] FIG. 18B is a side-view illustration depicting the atrial
cage in the collapsed configuration with a valve prosthesis
positioned therein in the collapsed form;
[0052] FIG. 19A is a side-view illustration of a delivery device
for transcatheter delivery depicting the atrial cage of FIG. 18A
without the valve as being positioned over the catheter for
percutaneous delivery; and
[0053] FIG. 19B is a side-view illustration of a delivery device
for transcatheter delivery depicting the atrial cage of FIG. 18B
with the valve as being positioned over the catheter for
percutaneous delivery.
DETAILED DESCRIPTION
[0054] The present invention relates to heart valves and, more
particularly, to a collapsible cage for percutaneous delivery and
implantation of an atrioventricular valve within an atrium of the
heart. The following description is presented to enable one of
ordinary skill in the art to make and use the invention and to
incorporate it in the context of particular applications. Various
modifications, as well as a variety of uses in different
applications will be readily apparent to those skilled in the art,
and the general principles defined herein may be applied to a wide
range of embodiments. Thus, the present invention is not intended
to be limited to the embodiments presented, but is to be accorded
the widest scope consistent with the principles and novel features
disclosed herein.
[0055] In the following detailed description, numerous specific
details are set forth in order to provide a more thorough
understanding of the present invention. However, it will be
apparent to one skilled in the art that the present invention may
be practiced without necessarily being limited to these specific
details. In other instances, well-known structures and devices are
shown in block diagram form, rather than in detail, in order to
avoid obscuring the present invention.
[0056] The reader's attention is directed to all papers and
documents which are filed concurrently with this specification and
which are open to public inspection with this specification, and
the contents of all such papers and documents are incorporated
herein by reference. All the features disclosed in this
specification, (including any accompanying claims, abstract, and
drawings) may be replaced by alternative features serving the same,
equivalent or similar purpose, unless expressly stated otherwise.
Thus, unless expressly stated otherwise, each feature disclosed is
only one example of a generic series of equivalent or similar
features.
[0057] Furthermore, any element in a claim that does not explicitly
state "means for" performing a specified function, or "step for"
performing a specific function, is not to be interpreted as a
"means" or "step" clause as specified in 35 U.S.C. Section 112,
Paragraph 6. In particular, the use of "step of" or "act of" in the
claims herein is not intended to invoke the provisions of 35 U.S.C.
112, Paragraph 6.
[0058] Please note, if used, the labels left, right, front, back,
top, bottom, forward, reverse, clockwise and counter clockwise have
been used for convenience purposes only and are not intended to
imply any particular fixed direction. Instead, they are used to
reflect relative locations and/or directions between various
portions of an object. Further details are provided below.
[0059] (1) Specific Details
[0060] As shown in FIGS. 1 through 15, this disclosure is directed
to a collapsible (and expandable) atrial cage 100. The atrial cage
100 is designed for percutaneous delivery and implantation of
atrioventricular valves within an atrium of the heart. The atrial
cage 100 provides a means for a transcatheter atrioventricular (AV)
valve (examples of which are depicted in FIGS. 7A through 7C) to be
securely placed and anchored at the AV junction (as shown between
FIGS. 16A and 16B). FIG. 16A depicts an interior-view illustration
of a heart chamber, depicting a native mitral valve annulus 1600,
while FIG. 16B depicts the atrial cage 100 and a bioprosthetic
mitral valve 700 securely anchored at the AV junction. Further
details regarding the atrial cage 100 and a corresponding valve 700
are provided below.
[0061] The collapsible atrial cage 100 is sized and shaped to fit a
patient atrium. The cage is securely attached or securely
attachable to a transcatheter AV valve prosthesis. Once deployed
and expanded in the atrium, the cage 100 is strong enough to
securely anchor the AV valve prosthesis in place (i.e., at an
atrioventricular junction such as mitral and/or tricuspid valve's
annulus). Through use of the wireform (on various embodiments) and
its shape, the atrial cage 100 is structured so as to not interfere
with atrial function.
[0062] In various embodiments and as shown in FIG. 1, the atrial
cage 100 is a wire cage (although not limited thereto) that is
formed and shaped to include an atrial portion 102 and a
ventricular portion 104. The atrial portion 102 and ventricular
portion 104 are separated by a valve juncture portion 106. The
ventricular portion 104 operates as an extension into the native
ventricle through which the AV junction encircles the cage 100
structure. Notably and when expanded as shown in the figures, the
atrial portion 102 and ventricular portion 104 each have a diameter
that is greater than the diameter of the valve juncture portion
106. The larger diameters of the atrium and ventricular portions
102 and 104 allow the atrial cage 100 to securely attach on
opposing sides of the AV juncture (with the valve juncture portion
106 positioned within the AV juncture) to anchor the AV valve
prosthesis to the AV juncture while avoiding unnecessary contact
with select areas of the atrial wall. Thus, due to the larger
diameters of the atrium and ventricular portions 102 and 104, the
atrial cage 100 is securely connected to and holds an AV valve in
place and, notably prevents the AV valve and atrial cage 100 from
sliding into the atrium or ventricle. For further understanding,
FIG. 2 through 6 provide rear, left, right, top, and bottom views,
respectively, of the atrial cage 100.
[0063] As noted above, the atrial cage 100 is formed to securely
hold a prosthetic AV valve at the AV junction. In various
embodiments, the AV valve is integrally formed as a part of the
atrial cage 100. However and in other embodiments, the AV valve is
separate part attached to the atrial cage 100 using any suitable
connection device or technique, non-limiting examples of which
include suture, mechanical interlock, and material fusion. For
example and regarding the mechanical interlock, the atrial cage 100
can be formed with one or more cage interlocks that are shaped to
interlock with a corresponding valve catch. While the cage
interlocks 110 are depicted throughout FIGS. 1 through 6, they are
more clearly seen in the top and bottom views provided in FIGS. 5
and 6, respectively. The non-limiting example as depicted
illustrates a set of three cage interlocks 110 on the cage 100.
Although not depicted, the catch or other parts of the valve can be
alternatively sutured or otherwise material fused to the cage 100
at the appropriate location.
[0064] However and as noted above, the cage interlocks 110 are
specifically shaped to interlock with and securely hold an AV
valve. A non-limiting example of such a suitable AV valve 700 is
depicted in FIGS. 7A through 7C and described in U.S. patent
application Ser. No. 15/598,210, filed on May 17, 2017, entitled,
"Collapsible Atrioventricular Valve Prosthesis" and published as
U.S. Patent Publication No. 2017-0252163, the entirety of which are
hereby incorporated herein by reference. The AV valve 700 includes
a frame 702 and a plurality of leaflets 704 separated by upstanding
prongs 706. In this non-limiting example, between each prong 706
there is at least one catch 708 formed on the frame 702 that
protrudes downward from the frame 702 (when the prongs 706 project
upward). The catch 708 is an appendix or fixture that is shaped
(e.g., includes a hook-shaped or curvature) to act as a catch or
clamp to hold the valve frame 702 secure on the atrioventricular
junction or at the atrial side of the heart when installed and
deployed. Alternatively, when used with an atrial cage, the catch
708 can be securely held by the cage interlocks 110 which grasp and
securely hold the catch 708 and corresponding valve 700.
[0065] For further understanding, FIGS. 8A through 8C provide
front, bottom, and isometric, close-up view illustrations of the
cage interlock 110. FIGS. 8A through 8C are to be contrasted with
FIGS. 9A through 9C, which depict a valve 700 and its catch 708 as
secured with the interlocks 110 illustrated in FIGS. 8A through 8C.
As can be appreciated by those skilled in the art, there are a
number of interlock 110 shapes that can be employed to interlock
with the catch 708. For example and as depicted in FIG. 17, the
interlock 110 can be formed as a simple loop shape through which
the catch 708 is formed and shaped to slip through and engagingly
lock with the loop shape of the interlock 110.
[0066] Another non-limiting example is depicted throughout the
figures and clearly shown in FIG. 8C. In this non-limiting example,
the interlock 110 includes a tip clasp 800 and a base clasp 802.
The tip clasp 800 is formed to engagingly receive and securely hold
the tip of the catch while the base clasp is formed to at least
partially wrap around the base of the catch. This aspect is shown
in FIG. 9C, which depicts a tip 900 of the catch 708 as nested into
the tip clasp 800 while the base clasp 802 partially wraps around
the base 902 of the catch 708. The base clasp 802 operates as a
locking hoop similar to the aspect as depicted in FIG. 17; however,
the added tip clasp 800 further secures the catch 708 to prevent or
otherwise minimize any rocking, slipping, or unwanted motion of the
valve 700.
[0067] This aspect is further illustrated in FIGS. 10 through 15,
which provide front, rear, left, right, top and bottom-view
illustrations, respectively, of the atrial cage 100 and
corresponding interlock 110 as connected with a valve 700. Notably,
the tip clasp 800 can be seen in most figures, while the base clasp
802 is best seen in FIG. 15.
[0068] As noted above, the atrial cage 100 is collapsible (as shown
in FIGS. 18A and 18B and expandable (as shown in FIGS. 1 through 6
and 8A through 16B). The cage 100 can be collapsed along with an
attached valve (as shown in FIG. 18B) so that it can be delivered
using any suitable transcatheter delivery device. A non-limiting
example of a suitable delivery device is disclosed in U.S. patent
application Ser. No. 15/627,360, filed on Jun. 19, 2017 and
published as U.S. Patent Publication No. 2017-0360557, entitled,
"Delivery System for Percutaneous Delivery And Implantation Of
Atrioventricular Heart Valves," the entirety of which are
incorporated herein by reference. Due to its wireframe construction
and shape, the cage 100 can be collapsed to allow for secure
placement via transcatheter delivery and deployment, including by
transfemoral, transaortic, transapical, or trans-septal access.
During transfemoral, transaortic, and transapical access, the cage
100 is deployed in the atrium prior to deployment of the AV valve.
In another aspect, during trans-septal access, the AV valve is
deployed prior to the cage 100 being deployed. Once in the desired
location, the cage 100 can be expanded using any suitable
mechanism, technique or device. In one embodiment, the cage 100 is
self-expandable. The cage 100 can self-expand by using a shape
memory material such as Nitinol or any other suitable
self-expanding material (as an example, the cage can be formed of
Nitinol wire or other suitable material or forms). As a
non-limiting example, the cage 100 can be shape set in the expanded
form such that when delivered and released from a delivery device
the cage 100 self-expands. In another embodiment, the cage is
balloon-expandable. In one embodiment, the cage 100 is securely
attached to the AV valve prosthesis before delivery to the atrium
over the transcatheter delivery system. In another embodiment, the
cage 100 is delivered separately to the atrium and the prosthetic
AV valve is subsequently deployed and attached or interlocked to
the cage. In yet another embodiment, the cage 100 can be laser-cut
from a tube.
[0069] For example and further understanding, FIG. 18A provides a
side-view illustration depicting the atrial cage 100 in a collapsed
configuration without a valve prosthesis therein, while FIG. 18B
depicts the atrial cage 100 in the collapsed configuration with the
valve prosthesis 700 positioned the atrial cage 100. As such and as
can be appreciated by those skilled in the art, the cage 100 is
collapsible over a delivery catheter and is deplorable either
separately to have a valve being attached to it consequently or
collapsed along with a transcatheter valve 700 already attached to
it and both are collapsed over a delivery catheter. This is further
illustrated in FIGS. 19A and 19B. FIG. 19A is a side-view
illustration of a delivery device 1900 for transcatheter delivery
depicting the atrial cage 100 of FIG. 18A without the valve as
being positioned over the catheter for percutaneous delivery, while
FIG. 19B is a side-view illustration of the delivery device 1900
depicting the atrial cage 100 of FIG. 18B with the valve 700
therein as being positioned over the catheter for percutaneous
delivery. As noted above, any suitable delivery device can be
employed to deliver the atrial cage and/or valve in accordance with
various embodiments of the present invention, a non-limiting
example of which includes the delivery device as described in U.S.
Patent Publication No. 2017-0360557 and as referenced above. As
such, this disclosure is also directed to a method for delivery
using such a delivery device.
[0070] In other embodiments, the cage 100 is comprised in whole or
part of a dissolvable material that is bioabsorbable,
bioresorbable, biodegradable, or naturally-dissolving, where the
cage may gradually resorb or dissolve away after some time period
and after the AV valve prosthesis becomes secured to the AV
juncture through natural or artificial processes. Non-limiting
examples of such bioabsorbable, bioresorbable, biodegradable, or
naturally-dissolving material(s) include base materials that are
either metals or polymers, such as iron, magnesium, zinc and their
alloys, a poly(L-lactide) polymer similar to that in dissolvable
stitches, a drug-eluting material, a mixture of poly-D, L-lactide
(PDLLA) and everolimus, markers, such as a pair of radio-opaque
platinum markers that allow the device to be visualized during
angiography, etc.
[0071] In one embodiment, the cage 100 is sized and shaped
according to medical imaging means to fit or conform with atrial
anatomy to facilitate orientation and positioning of the cage as
well as to facilitate orientation and positioning of the attached
or to be attached AV valve. For example, using magnetic resonance
imaging or other imaging technologies, the shape of a patient's
atrium and ventricle can be determined to allow a manufacturer to
customize the shape of the cage 100 to match that of the patient's
anatomy.
[0072] In one embodiment, the cage 100 is custom-sized and shaped
to fit a specific patient's anatomy including incorporating some
means of 3D scanning. In yet another aspect, the cage 100 is
produced by some means of 3D printing.
[0073] In one embodiment, the cage 100 is sized and shaped such
that once deployed and expanded, at least a part of the cage 100 is
in contact with the atrial wall (e.g. where the cage is sized and
shaped to match the atrial cavity), or the cage 100 can be formed
such that some areas of the cage 100 may be in contact with the
atrial wall and some areas of the cage 100 may not be (e.g., where
the cage 100 is sized and shaped to anchor the AV valve prosthesis
to the AV juncture while avoiding unnecessary contact with select
areas of the atrial wall).
[0074] Finally, while this invention has been described in terms of
several embodiments, one of ordinary skill in the art will readily
recognize that the invention may have other applications in other
environments. It should be noted that many embodiments and
implementations are possible. Further, the following claims are in
no way intended to limit the scope of the present invention to the
specific embodiments described above. In addition, any recitation
of "means for" is intended to evoke a means-plus-function reading
of an element and a claim, whereas, any elements that do not
specifically use the recitation "means for", are not intended to be
read as means-plus-function elements, even if the claim otherwise
includes the word "means". Further, while particular method steps
have been recited in a particular order, the method steps may occur
in any desired order and fall within the scope of the present
invention.
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